ARAGON ONESHOT SYSTEM— 510(k) K081312

Substantially Equivalent

Aragon Surgical, Inc.

FDA 510(k) clearance K081312 for ARAGON ONESHOT SYSTEM, Substantially Equivalent on 2008-10-31. Applicant: Aragon Surgical, Inc..

Clearance details

Applicant: Aragon Surgical, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2008-05-09
Decision date: 2008-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.